Conformis restor3d Cordera Hip System recall — FDA Z-1569-2025
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
21,924 detailed records are currently available in this category.
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Potential for collimator to fall as a result of incorrect installation.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system…
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material…
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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